Cleared Traditional

K811815 - UROPAPER EIKEG

K811815 is an FDA 510(k) clearance for UROPAPER EIKEG, manufactured by Syn-Kit, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K811815 · Syn-Kit, Inc. · Hematology device
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Dec 1981
Decision
167d
Days
Class 2
Risk

K811815 is an FDA 510(k) clearance for the UROPAPER EIKEG. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1981 after a review of 167 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syn-Kit, Inc. devices

FDA 510(k) Submission Details - K811815

510(k) Number K811815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1981
Decision Date December 10, 1981
Days to Decision 167 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 113d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 57
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K811815.
GASTROCCULT TM
K821884 · Smithkline Diagnostics, Inc. · Oct 1982
FE-CULT PLUS
K820072 · Gamma Biologicals, Inc. · Mar 1982
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 1982
FE-CULT PLUS
K811752 · Gamma Biologicals, Inc. · Nov 1981
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980